Fentanyl sublingual - Orexo

Drug Profile

Fentanyl sublingual - Orexo

Alternative Names: Abstral; EN-3267; Fentanyl citrate sublingual tablets; Fentanyl transmucosal - Orexo; KW-2246; OX-20; Rapinyl

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Orexo
  • Developer Galena Biopharma; Kyowa Hakko Kirin; Kyowa Kirin International; Paladin Labs
  • Class General anaesthetics; Opioid analgesics; Piperidines; Small molecules
  • Mechanism of Action Opioid mu receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cancer pain

Most Recent Events

  • 03 May 2016 Re-launched for Cancer pain by Sentnyl Therapeutics in USA (Sublingual)
  • 03 May 2016 The US label for sublingual fentanyl carries a black box warning related to the risk of respiratory depression, medication errors and abuse potential
  • 18 Apr 2016 ProStrakan is now called Kyowa Kirin International
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